We are analyzing https://link.springer.com/article/10.1186/s12967-015-0632-8.

Title:
Phase I clinical trial of autologous NK cell therapy using novel expansion method in patients with advanced digestive cancer | Journal of Translational Medicine
Description:
NK cells can destroy tumor cells without prior sensitization or immunization. Tumors often lose expression of MHC molecules and/or antigens. However, NK cells can lyse tumor cells in a non-MHC-restricted manner and independent of the expression of tumor-associated antigens. NK cells are therefore considered ideal for adoptive cancer immunotherapy; however the difficulty of obtaining large numbers of fully functional NK cells that are safe to administer deters its clinical use. This phase I clinical trial seeks to address this obstacle by first developing a novel system that expands large numbers of highly activated clinical grade NK cells, and second, determining if these cells are safe in a mono-treatment so they can be combined with other reagents in the next round of clinical trials. Patients with unresectable, locally advanced and/or metastatic digestive cancer who did not succeed with standard therapy were enrolled. NK cells were expanded ex vivo by stimulating PBMCs with OK432, IL-2, and modified FN-CH296 induced T cells. Patients were administered autologous natural killer cell three times weekly via intravenous infusions in a dose-escalating manner (dose 0.5 × 109, 1.0 × 109, 2.0 × 109 cells/injection, three patients/one cohort). Total cell population had a median expansion of 586-fold (range 95–1102), with a significantly pure (90.96 %) NK cell population. Consequently, NK cells were expanded to approximately 4720-fold (range 1372–14,116) with cells being highly lytic in vitro and strongly expressing functional markers such as NKG2D and CD16. This NK cell therapy was very well tolerated with no severe adverse events. Although no clinical responses were observed, cytotoxicity of peripheral blood was elevated approximately twofolds up to 4 weeks post the last transfer. We successfully generated large numbers of activated NK cells from small quantities of blood without prior purification of the cells. We also determined that the expanded cells were safe to administer in a monotherapy and are suitable for the next round of clinical trials where their efficacy will be tested combined with other reagents. Trial Registration: UMIN UMIN000007527
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28 years and 1 months (reg. 1997-05-29).

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Keywords {🔍}

cells, cell, cancer, patients, article, pubmed, google, scholar, clinical, expanded, killer, cas, natural, expansion, blood, therapy, pbmcs, patient, day, adoptive, cytotoxicity, table, study, trial, immunotherapy, method, population, activity, dose, autologous, tumor, cohort, cytotoxic, culture, administration, japan, fig, cxcr, advanced, range, peripheral, transfer, human, functional, median, fold, observed, safety, data, phase,

Topics {✒️}

antigen-specific t-cell clones complete response + partial response + sd contributed reagents/materials/analysis tools expand nk cells natural killer lymphocytes natural killer cells nk cell-based immunotherapy nk cell-based therapies nk cell-based therapy kir ligand-mismatched donor saline based-solution supplemented 6-year single-institution experience kir-ligand mismatch phenomenon heat-inactivated autologous plasma wilcoxon signed-rank test article download pdf iseikai hyakumanben clinic killer cell attack cell surface markers cytokine-based expansion method natural killer natural killer bio-plex manager software tunon-de-lara jm nk cell-based monotherapy adding gt-t510 medium anti-kir antibody enhancement graft-versus-host disease experimental release − spontaneous release maximum release − spontaneous release gt-t551 culture medium gt-t510 culture medium full access modified fn-ch296 induced tumor-specific monoclonal antibodies high log-scale expansion fluorescent-labeled target cells presented progressive disease toshikazu yoshikawa nk cell therapy cancer cell therapy anti-cd3 monoclonal antibody nk cell products adoptive cellular immunotherapy nk cell population privacy choices/manage cookies activated nk cells renal cell carcinoma human serum albumin nk-cell exhaustion

Questions {❓}

Ramnath N, Tan D, Li Q, Hylander BL, Bogner P, Ryes L, Ferrone S (2006) Is downregulation of MHC class I antigen expression in human non-small cell lung cancer associated with prolonged survival?
Vivier E, Raulet DH, Moretta A, Caligiuri MA, Zitvogel L, Lanier LL, Yokoyama WM, Ugolini S (2011) Innate or adaptive immunity?

Schema {🗺️}

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               type:PostalAddress
            type:Organization
      name:Masashige Tanabe
      affiliation:
            name:CDM Center, Takara Bio Inc
            address:
               name:CDM Center, Takara Bio Inc, Otsu, Japan
               type:PostalAddress
            type:Organization
      name:Tatsuji Enoki
      affiliation:
            name:CDM Center, Takara Bio Inc
            address:
               name:CDM Center, Takara Bio Inc, Otsu, Japan
               type:PostalAddress
            type:Organization
      name:Junichi Mineno
      affiliation:
            name:CDM Center, Takara Bio Inc
            address:
               name:CDM Center, Takara Bio Inc, Otsu, Japan
               type:PostalAddress
            type:Organization
      name:Yuji Naito
      affiliation:
            name:Kyoto Prefectural University of Medicine
            address:
               name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
               type:PostalAddress
            type:Organization
      name:Yoshito Itoh
      affiliation:
            name:Kyoto Prefectural University of Medicine
            address:
               name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
               type:PostalAddress
            type:Organization
      name:Toshikazu Yoshikawa
      affiliation:
            name:Kyoto Prefectural University of Medicine
            address:
               name:Department of Cancer ImmunoCell Regulation, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Iseikai Hyakumanben Clinic, Kyoto, Japan
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Department of Cancer ImmunoCell Regulation, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Center for Education Research and Development, Kyoto Gakuen University, Kyoto, Japan
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Department of Cancer ImmunoCell Regulation, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:CDM Center, Takara Bio Inc, Otsu, Japan
      name:CDM Center, Takara Bio Inc, Otsu, Japan
      name:CDM Center, Takara Bio Inc, Otsu, Japan
      name:CDM Center, Takara Bio Inc, Otsu, Japan
      name:CDM Center, Takara Bio Inc, Otsu, Japan
      name:CDM Center, Takara Bio Inc, Otsu, Japan
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
      name:Department of Cancer ImmunoCell Regulation, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan

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